CLINICAL TRIALS PROFILE FOR
APIDRA SOLOSTAR

Clinical Trial Listing

Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents

Completed

Sanofi

Phase 3

The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and
effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents
with type 1 diabetes mellitus.

The purpose of this study is to show the non-inferiority of insulin glulisine administered
with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c
(HbA1c), from baseline to study week 24.

The purpose of this study is to compare the change in weight from baseline to study week 52
in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal
Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.

Primary objective
- To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration
of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin
glulisine across healthy subjects in 4 different BMI-classes (lean, overweight,
moderately obese, severely obese), using the euglycemic clamp technique with the
Biostator™.
Secondary objective
- To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous
administration of insulin glulisine in comparison to insulin lispro and to investigate
the safety and tolerability after subcutaneous administration of insulin glulisine in
comparison to insulin lispro.

High blood glucose levels in hospitalized patients with diabetes are associated with
increased risk of medical complications. Improved glucose control with insulin injections
may improve clinical outcome and prevent some of the hospital complications. It is not
known; however, what is the best insulin regimen in hospitalized patients. The use of
repeated injections of regular insulin (known as sliding scale regimen) is one of the most
commonly used insulin regimen for glucose control in hospitalized patients with diabetes.
Recently, the combination of basal and rapid acting insulins has been shown to improve
glucose control with lower rate of hypoglycemia (low blood sugar).

High blood glucose levels in hospitalized patients with diabetes are associated with
increased risk of medical complications. Improved glucose control with insulin injections
may improve clinical outcome and prevent some of the hospital complications. It is not
known; however, what is the best insulin regimen in hospitalized patients. The use of
repeated injections of regular insulin (known as sliding scale regimen) is one of the most
commonly used insulin regimen for glucose control in hospitalized patients with diabetes.
Recently, the combination of basal and rapid acting insulins has been shown to improve
glucose control with lower rate of hypoglycemia (low blood sugar).

High blood glucose levels in hospitalized patients with diabetes are associated with
increased risk of medical complications. Improved glucose control with insulin injections
may improve clinical outcome and prevent some of the hospital complications. It is not
known; however, what is the best insulin regimen in hospitalized patients. The use of
repeated injections of regular insulin (known as sliding scale regimen) is one of the most
commonly used insulin regimen for glucose control in hospitalized patients with diabetes.
Recently, the combination of basal and rapid acting insulins has been shown to improve
glucose control with lower rate of hypoglycemia (low blood sugar).

To collect effectiveness and safety data during the treatment with Apidra glulisine
(HMR1964) by means of subcutaneous injections to patients with Diabetes Mellitus 1st type
during 12 weeks-active phase.

Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus

Completed

Sanofi

Phase 4

Primary Objectives:
To determine the effect of insulin glulisine on glycemic control (HbA1c, FBG & PPBG) from
baseline to the end of the study.
Secondary Objectives:
To evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the
incidence of hypoglycemia and other adverse events.

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